Kornimate/medical-research-clean huggingface dataset:
svc and its relationship to cvp measurements in liver transplantation

Conditions: Liver Failure

Summary: consecutive patients undergoing liver transplant surgery will be included in the study. before surgical incision, during the preanhepatic phase, during the anhepatic phase, during the postanhepatic phase and following closure of the deep fascial layer of the anterior abdominal wall simultaneous measurement of svc diameter, sbc collapsibility index and cvp will be recorded.

central venous pressure (cvp) measured invasively through a central venous catheter in the internal jugular vein or through a right atrial port of a pulmonary artery catheter is commonly used during liver transplant surgery. cvp measurements at the svc-ra junction are a function of circulating blood volume, right ventricle function, intrathoracic pressure. cvp measurements can also be affected by the presence of tricuspid regurgitation. because central venous pressure measurements are determined by several factors and do not predict the response to subsequent fluid bolus administration, they are considered "static measures" and are poor indicators of fluid responsiveness. given the entirely intrathoracic location of the superior vena cava (svc), its diameter and collapsibility with positive pressure ventilation it is a potentially attractive method of non-invasively estimating cvp. svc diameter and collapsibility index, dynamic measures of fluid responsiveness have been successfully utilized as echocardiographic indices for fluid responsiveness in ventilated septic patients. whether svc collapsibility is correlated with cvp measurements in liver transplant patients is not known. consecutive patients undergoing liver transplant surgery will be included in the study. before surgical incision, during the preanhepatic phase, during the anhepatic phase, during the postanhepatic phase and following closure of the deep fascial layer of the anterior abdominal wall simultaneous measurement of svc diameter, sbc collapsibility index and cvp will be recorded.

Eligibility criteria:
inclusion criteria: * 18 years of age * undergoing liver transplantation surgery (cadaveric and living related) exclusion criteria: * contraindication to transesophageal echocardiography
phase i clinical trial of grid therapy in pediatric osteosarcoma of the extremity

Conditions: Osteosarcoma in Children; Radiation Toxicity

Summary: the primary objective of this study is to evaluate the toxicity profile of grid therapy using dose levels of 10gy, 15 gy and 20gy in pediatric osteosarcoma of the extremity.

subjects will receive grid radiotherapy. grid radiation therapy is considered a standard radiation therapy method however is not typically used in pediatric osteosarcoma patients. this protocol will evaluate whether or not the use of this therapy will provide benefit to this patient population.

Eligibility criteria:
inclusion criteria: * history of cytological or histological documentation of non-metastatic extremity osteosarcoma. * 5-21 years of age. * subject is eligible for routine chemotherapy and routine surgery for the treatment of non-metastatic extremity osteosarcoma * informed consent is obtained exclusion criteria: * females with a positive urine pregnancy test. * unable to comply with study procedures
a study with sage-547 for super-refractory status epilepticus

Conditions: Super-Refractory Status Epilepticus

Summary: this is a randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of sage-547 administered as a continuous intravenous infusion to subjects in super-refractory status epilepticus (srse).


Eligibility criteria:
inclusion criteria: * subjects two (2) years of age and older * subjects who have: * failed to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial anti-epileptic drug \[aed\] treatment), according to institution standard of care, and; * failed to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent control aed), according to institution standard of care, and; * not previously been administered a third-line agent but have been admitted to an intensive care unit with the intent of administering at least one third-line agent for at least 24 hours; or who have previously failed zero, one or more wean attempts from third-line agents and are now on continuous intravenous infusions of one or more third-line agent and in an eeg burst or seizure suppression pattern; or who have previously failed one or more wean attempts from third-line agents and are now either not on a continuous intravenous infusion of at least one third-line agent or are on a continuous intravenous infusion of one or more third-line agent but not in an eeg burst or seizure suppression pattern exclusion criteria: * subjects with srse due to anoxic/hypoxic encephalopathy with highly malignant/ malignant eeg features * children (subjects aged less than 17 years) with an encephalopathy due to a rapidly progressing underlying neurological disorder * subjects who have any of the following: 1. a glomerular filtration rate (gfr) low enough to warrant dialysis but for whatever reason, dialysis is not planned or non-continuous dialysis planned (that would not adequately remove captisol®); 2. severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use; 3. fulminant hepatic failure; 4. no reasonable expectation of recovery (for instance, a likely outcome is persistent vegetative state) or life-expectancy, in the experience of the investigator, is less than 30 days. * subjects who are being administered more than three third-line agents concomitantly or in whom the qualifying wean cannot be completed per protocol
study of the role of tissular maternofetal alloimmunization in placentation pathologies

Conditions: Recurrent Pregnancy Losses; Preeclampsia; Intervillositis

Summary: justification: we have recently demonstrated that maternofetal alloimmunization was not limited to blood cells: maternal alloimmunization against a glomerular podocyte antigen expressed by the placenta can induce neonatal membranous glomerulonephritis. early recurrent pregnancy losses, preeclampsia and intervillositis are obstetrical pathologies which share an anomaly of placentation. pathophysiology of these diseases is not yet fully understood; nevertheless the hypothesis of an incompatibility between mother and child is often mentioned. the aim of this project is to detect and study the cases of recurrent pregnancy losses, preeclamspia and intervillositis which could be induced by tissular maternofetal alloimmunization. materials and methods: patients suffering from recurrent pregnancy losses of unknown origin, preeclamspia or intervillositis will be included in this project. mothers' sera will be studied by indirect immunofluorescence and western blot on placental biopsies from different origins and gestational ages. this stage will enable us to detect possible maternal allo-antibodies. after detecting and revealing antibodies, nature of the target antigen will be identified by immunoprecipitation of placental extracts, using the positive sera. immunoprecipitation will be followed by a mass spectrometry analysis of detected proteins. expected results: this study will enable us: * to detect new cases of tissular maternofetal alloimmunization * to improve our knowledge of mechanisms leading to anomalies of placentation * to carry out a specific, preventive therapeutic approach for cases induced by tissular alloimmunization. key words: recurrent pregnancy losses, preeclampsia, intervillositis, maternofetal alloimmunization.


Eligibility criteria:
inclusion criteria: * recurrent pregnancy losses : patient having or having suffered from at least 3 consecutive, unexplained recurrent pregnancy losses, during the first 3 months of pregnancy, with the same paerson/man. * preeclampsia : blood pressure \> 140/90 mm hg ; proteinuria \> 0,3 g/ 24 h * intervillositis : patient suffering or having suffered from intervillositis exclusion criteria: * recurrent pregnancy losses : uterine pathology, endocrine pathology, autoimmune pathology, coagulation and hemostasis pathology, karyotype anomaly. * preeclampsia : pre-existing high blood pressure, pre-existing diabetes, pre-existing renal disease, antiphospholipid antibodies syndrome * intervillositis : intervillositis with villositis

Keywords: recurrent pregnancy losses preeclampsia intervillositis maternofetal alloimmunization
group cognitive behavioral therapy (cbt i) vs. quetiapine for residual insomnia impairing recovery among elderly with stable major affective disorders

Conditions: Insomnia

Summary: the purpose of this pilot study is to assess feasibility and patient accessibility in order to design an adequately powered study to compare group cognitive behavioral therapy for insomnia (cbt-i) to quetiapine in non-demented patients aged 60 years or older with controlled bipolar disorder (i or ii) or major depressive disorder who suffer from residual insomnia.


Eligibility criteria:
inclusion criteria: 1. age greater or equal to 60 years. 2. patients with history of major affective disorder, including bipolar disorder type i or type ii or major depressive disorder, as assessed by the structured clinical interview for dsm-iv (scid), currently in remission. 3. difficulty starting or initiating sleep four or more times/week for at least 3 months by history. 4. total pittsburg sleep quality index \>5. exclusion criteria: 1. patient in an acute mood episode as assessed by scid 2. patients with sleep disruptive medical problems including: sleep apnea, restless leg syndrome, periodic limb movement, parasomnia, congestive heart failure, chronic pain and chronic obstructive pulmonary disease as assessed by medical history and medical record review. 3. patients with schizophrenia, primary anxiety disorder and active substance abuse as determined by scid. 4. patients on or with history of failure or intolerance to respond to quetiapine. 5. patient with positive alcohol use disorders identification test (audit) with a total score above 8. 6. patients with dementia brain degenerative diseases, cognitive disorders and mini mental status examination (mmse) score of less or equal to 24. 7. patients who are in an acute depressive, manic, hypomanic or mixed state as reflected by scid 8. patients on concurrent sedating medications that would confound interpretation of the results. this is operationalized as follow: sedating medications must be present and stable dosage for at least 14 days prior to enrollment in the study. if the medication is not prescribed as a primary sleep aid, it will be continued. our rationale is that patients may need these medications and the initial sedating effect will have plateaued by 14 days. however, medications prescribed to assist insomnia will be discontinued as they are not effective for the subjects who otherwise meet inclusion ad exclusion criteria for the current study. medications will be tapered as clinically indicated after the patients sing informed consent and prior to baseline assessment.

Keywords: insomnia elderly affective disorders
feasibility of integrating the outcomes4me smartphone navigation application into the care management of breast cancer patients

Conditions: Breast Cancer; Invasive Breast Cancer; Metastatic Breast Cancer; Breast Carcinoma; Metastatic Breast Carcinoma

Summary: this study aims to investigate the role of a mobile health app, outcomes4me, in the navigation of care for people with breast cancer.

this protocol is a single arm pilot study of a novel breast cancer navigation app that is intended to assist patients with breast cancer understand their diagnosis and treatment options (both as part of standard of care practice and clinical trials) and manage their care, through treatment and symptom tracking. patients will also be able to share information and get news via the app relevant to their cancer subtype. results from this intervention will inform future clinical integration efforts, improve patient-centeredness of such an app-based health content and data platform, and inform the design of a larger, randomized study to demonstrate an improvement in patients' outcomes as well as enhanced real-world evidence (rwe) data collection.

Eligibility criteria:
inclusion criteria: * 18 years or older, with histologically or cytologically confirmed invasive breast cancer stage i-iv * must be on, or planning to be on within 4 weeks of registration, active therapy, with the intent to receive some element of active therapy \> 28 days after registration * must be able to understand, read, and write in english and be able to sign informed consent * must have an apple or android smart phone that they are able to use and download the outcomes4me app on * must have the ability to access the internet at least once per week via their smart phone (having a computer is not required) exclusion criteria: * participations seen for consultation opinion only and are not planning to receive some element of active treatment from an mgh medical or radiation oncology provider at mgh (boston or waltham sites) during the 12-week study period

Keywords: invasive breast cancer metastatic breast cancer nccn guidelines patient navigation treatment options clinical trial options symptom management
real world evaluation of advisor pro in clinical practice

Conditions: Type1diabetes

Summary: to assess the integration of the dreamed advisor pro tool into a real-world clinical practice using both in person and virtual visits to assess benefits in glycemia, as measured by the glucose management indicator and other glucose metrics. to determine acceptability of the dreamed advisor pro tool both from a person with diabetes as well as a health care provider perspective. to quantify the potential reimbursement potential that could be generated with use of the dreamed advisor pro.


Eligibility criteria:
inclusion criteria: 1. participant with type 1 diabetes 2. age ≥ 6 years to \<30 years 3. using insulin infusion pump (csii) therapy including those with low glucose suspend and predictive low glucose suspend features 1. insulin pump must not use automated insulin delivery (closed loop, artificial pancreas) 2. total daily dose of insulin must be greater than 0.5 units/kg/day 4. participants / parents are required to have minimum computer skills and access to a computer in order to upload their personal devices (pump, bg meter etc) to tidepool. 5. participants using dexcom sensors will allow access to their account for the study duration 6. participants not using cgm must agree to test bg at least 4 times a day at appropriate intervals 7. participants / parents will have to have a smartphone (apple or android and windows) exclusion criteria: 1. an episode of diabetic ketoacidosis within the month prior to study entry 2. any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patient's safety, 3. current participation in any other interventional study 4. female subject who is pregnant or lactating or planning to become pregnant within the planned study duration 5. severe hypoglycemia within six months prior to enrollment as defined by the ada and endocrine society 6. current use of the following medications: medications that are used to lower blood glucose such as pramlintide, metformin and glp-1 analogs. beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (anticoagulant therapy e.g. plavix, lmw heparin, coumadin, immunosuppressant therapy) 7. participants suffers from an eating disorder
use of indocyanine green during pelvic lymph node dissection in prostate cancer.

Conditions: Prostate Cancer; Lymph Node Metastases

Summary: standard treatment of local or locally advanced prostate cancer is radical prostatectomy (rrp) surgery. during rrp in certain patients extended lymph node dissection (elnd) is recommended. to detect eligible patients for elnd some nomograms based on clinical factors of them is used. the briganti nomogram is one of them. if the patient has 7% or more probability on briganti nomogram, then elnd is recommended. but elnd is complicated surgical procedure and may cause labor lost and cost. it is aimed here to show whether the icg based fluorescence imaging during laparoscopy may yield higher accuracy to detect metastatic lns than the conventional elnd?

50 patients with diagnosis of local or locally advance prostate cancer and having ln invasion probability between 7-50% on 2018 briganti nomogram will be included to this study. before laparoscopic radical prostatectomy (lrrp), icg is injected left and right lobe of the propagate during cystoscopy. extended lnd is performed in all patients. but before it, fluorescence imaging will be done, and icg positive lymph nodes (ln) are dissected and sent pathology separately. positive ln yield pf icg guided lnd and conventional lnd is compared.

Eligibility criteria:
inclusion criteria: * histologically confirmed locally limited prostate cancer; * intermediate or high risk tumor * recommended and planned prostatectomy; * completed and signed written consent; * voluntarily agreement to participate in this study * age of the study participants ≥ 18 years. exclusion criteria: * allergic reaction to active ingredient (indocyanine green); * iodine allergy; * hyperthyroidism; * high-grade renal impairment; * high-grade hepatic insufficiency; * unwillingness to the storage and disclosure of pseudonymous disease and personal data * psychiatric pre-existing conditions or other circumstances that make a cooperation by the patient in question

Keywords: indocyanine green based fluorescence imaging extendend lymph node dissection prostate cancer
randomized controlled trial of dietary advice in primary care to promote healthy feeding of infants

Conditions: Breast Feeding

Summary: a cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.

a cluster randomized controlled trial. twenty health care service sites were randomly assigned to the intervention or control groups. health care workers of the intervention health care service sites received training based on the programme "ten steps for healthy feeding for children from birth to two years old". pregnant women, in their third term, were enrolled in the study. at 6 and 12 months of age, the mothers were interviewed at home using a semi-structured questionnaire with pre-coded close- and open-ended questions and the children were evaluated.

Eligibility criteria:
inclusion criteria: - all pregnant women in the last quarter of the gestation. exclusion criteria: * hiv-positive mothers * congenital malformation

Keywords: health plan implementation feeding and eating disorders of childhood breast feeding overweight child infant nutrition physiology public health
pilot investigation of behavioral alternatives to indoor tanning

Conditions: Skin Cancer

Summary: the goal of this research is to develop and test the feasibility of an intervention that stimulates uptake of healthy alternatives to tanning by providing free access to them for a limited time. free access gives participants a low-risk opportunity to try something new that is consistent with their motivations. free access also allows them to experience the reinforcing properties of the alternatives which could prime continued use after the free trial period. the objective of the present study is to determine the feasibility and short-term efficacy of providing free alternatives to indoor tanners in an effort to "nudge" them to switch from indoor tanning to healthy alternatives.

melanoma is the second most common cancer diagnosed in young women and is responsible for nearly 8,000 us deaths per year. exposure to ultraviolet radiation (uvr) increases risk for melanoma. the international agency for research on cancer assigned indoor tanning (it; use of tanning beds or booths), as a class 1 carcinogen joining arsenic, asbestos, and mustard gas. unfortunately, interventions educating tanners about the risks have not been very effective. many tanners are more motivated by the immediate consequences of tanning than the delayed consequence of possibly getting cancer. research shows the primary motivation for indoor tanning is to improve physical appearance, but a secondary motivation is stress reduction. behavioral economics theory suggests that the rate of a behavior depends on 1) the reinforcing value of that behavior relative to alternatives, 2) the cost of engaging in the behavior relative to alternatives, and 3) the availability of the behavior relative to alternatives. the purpose of the present study is to determine whether exposure to healthy alternatives changes the behavior of indoor tanners. the investigators will randomize tanners to conditions differing in physical appearance and stress reduction alternatives to determine whether they can get their motivational needs met in healthier ways.

Eligibility criteria:
inclusion criteria: * female * ages 16-65 * report minimum of 10 indoor tanning visits in the last year with intentions to continue exclusion criteria: * ages \ 65 * pregnant, breastfeeding, or planning to become pregnant during the study period * reporting less than 10 indoor tanning visits per year * no intention to continue indoor tanning * using sunless tanning more than once in the last year and ever in the last 3 months * physically limited to do yoga or dance classes * dha allergy * inability to consent * prisoners
tranexamic acid in the prevention of postpartum hemorrhage in elective caesarean section

Conditions: Postpartum Hemorrhage; Tranexamic Acid

Summary: in obstetrics, postpartum haemorrhage (pph) continues to be a major contributor to maternal morbidity and mortality worldwide. uterine atony is the most common cause of pph, and the prophylactic use of uterotonics, specifically oxytocin, is the standard of care for pph prophylaxis. it is believed that tranexamic acid (txa) can enhance the hemostatic process further by inhibiting the fibrinolytic system. txa is an antifibrinolytic that has been studied in many different patient population for its use in reducing blood loss ranging from gynaecological and non gynaecological surgeries, to trauma patients. it has been found to reduce mortality in treatment of patients with pph, and recent evidence have found promising results in its use for prophylaxis of pph.


Eligibility criteria:
inclusion criteria: * all english speaking patients * above 21 year old * undergoing elective caesarean section. exclusion criteria: * known/suspected placenta accreta antenatally * contraindications to syntocinon and tranexamic acid such as hypersensitivity to these medications * known thrombophilia or coagulopathy * history of thromboembolic events * severe cardiac/renal/liver disease * poorly controlled hypertension /severe preeclampsia (bp \> 160/100)/eclampsia